CellGenix® rh TNF-α

GMP and Preclinical grade

CellGenix Recombinant Human TNF-α reliably stimulates the maturation of immature dendritic cells (DCs). CellGenix rh TNF-α is produced in our dedicated animal-free facility ensuring maximum safety for optimal use in ATMP manufacturing.

General Information

Tumor necrosis factor alpha (TNF-α) is a cytokine that plays a central role in inflammation, immune system development, apoptosis, and lipid metabolism. It is mainly produced by monocytes and macrophages as a response to infection, injury, or tumor burden. TNF-α can also be produced from a range of other cell types such as T cells, natural killer cells (NK cells) and neutrophils.

CellGenix TNF-α is used in the cell and gene therapy space for the ex vivo maturation of immature DCs.

GMP Grade

CellGenix GMP Recombinant Human TNF-α is produced following all applicable GMP guidelines and allows for the safe use in accordance with USP Chapter <1043> and Ph. Eur. General Chapter 5.2.12.

Our GMP cytokines are provided with documented evidence of purity, potency, consistency and stability. In combination with our expert regulatory and technical support this will help simplify your raw material qualification and validation efforts.

name
CellGenix® Recombinant Human Tumor Necrosis Factor-alpha
Source
E. coli
Formulation
Lyophilized
ANIMAL-DERIVED COMPONENT-FREE
CellGenix® GMP rh TNF-α
amount
Order Number
50  µg
1006-050
CellGenix® Preclinical rh TNF-α
amount
Order Number
50  µg
1406-050

CellGenix® rh TNF-α

Features

  • Produced in our dedicated animal-free facility
  • Compliant to USP Chapter <1043> and Ph. Eur. General Chapter 5.2.12 (GMP)
  • FDA Drug Master File available (GMP)

GMP & Preclinical Grade

  • Seamless transition from preclinical development to ATMP manufacturing

Applications

Highest GMP Quality Standard

  • High lot-to-lot consistency – save time on revalidations
  • Performance reliability – rely on consistent product performance
  • Highest purity – ensure the safety of your ATMP
  • Extremely low endotoxin levels – improve safety and reproducibility
  • Expert regulatory & technical support – rely on experience

Read more about our GMP Quality

 

Safe │ GMP Compliant │ Reliable

Technical Details

Source
Expressed in E. coli
Description

Human TNF-α, accession # P01375, Val77-Leu233

Formulation

Lyophilized from 200 µl of a 0.2 µm-filtered solution containing 1.5 mM potassium phosphate, 8.1 mM sodium phosphate, 2.7 mM potassium chloride and 137 mM sodium chloride, pH 7.5

Both product grades are produced under the same conditions in a GMP facility, ensuring an equal product quality and performance. We offer a more comprehensive QC testing including tighter specifications and documentation for our GMP products: Preclinical vs GMP

 PreclinicalGMP
Molecular weight17.5 kDa17.5 kDa
Purity≥ 95% as determined by SDS-PAGE≥ 97% as determined by SDS-PAGE
Activity≥ 10 x 106 IU/mg, calibrated against NIBSC #88/78620 – 80 x 106 IU/mg, calibrated against NIBSC #88/786
Batch specific activity on CoA
Endotoxin level< 1000 EU/mg≤ 50 EU/mg
Intended useIntended for preclinical ex vivo use. Not intended for human in vivo application.Intended for clinical ex vivo use. Not intended for human in vivo application.

 

Handling Instructions

Reconstitution

Recommended in sterile water to a final concentration of 250 µg/ml.

Shipment

Ambient temperature. Please refer to Technote to learn more about our shipment validation procedure.

Expiry

≥ 6 months from date of shipping. Please refer to Certificate of Analysis (CoA) for the exact expiry date.

Storage & Stability

Store lyophilized cytokine at -20°C to -80°C.

Store a 100 µg/ml reconstituted cytokine solution:

• 4 weeks at 2°C to 8°C under sterile conditions after reconstitution. Store in the original container. 

• 4 months at -20°C to -80°C under sterile conditions after reconstitution. Store in 60 µl aliquots in polypropylene cryogenic vials.

Avoid repeated freeze/thaw cycles.

Documents

Data

CellGenix GMP rh TNF-α has an activity of 20 – 80 × 106 IU/mg

The activity of GMP rh TNF-α was measured in a cell cytotoxicity assay using L929 cells. It was calibrated against NIBSC #88/786.

You can find the batch specific activity on the certificate of analysis (CoA).

Regulatory Support

We offer the following to assist you with your regulatory approval process:

  • Comprehensive documentation (e.g. DMFs, Regulatory Support Files, Certificates of Origin)
  • Outstanding QC support (e.g. extensive stability data)
  • The possibility to audit our production site
  • Detailed batch specific test results on our Certificates of Analysis
  • Change notifications prior to relevant changes

Customized solutions can be provided to meet special compliance needs. Contact our Regulatory Support Team for all your regulatory requests & questions:

Phone:     +49 761 88 88 9-302
Email:      regulatorysupport@cellgenix.com

 

In order to stay up-to-date with the international guidelines for raw materials, we are in constant interaction with regulatory authorities worldwide. In this regard, we amongst others helped defining the European guidelines which are outlined in the new general chapter Ph. Eur. monograph 5.2.12.

 

Regulatory Resources

Publications